In this episode, leading experts Tadeusz Hawrot; and Ellen James, Director of Research and Development, Small Pharma, discuss new research into psychedelic-assisted therapies and how the views surrounding psychedelics within the medical field are evolving.

In December, PAREA had a second meeting with EMA Chief Medical Officer. The Agency plans two significant activities in 2023:

i) an update of its depression guidelines which will include psychedelics

ii) publishing a paper on academic and regulatory challenges in PAT, to support their development.

EMA acknowledges that regulating psychotherapy is a challenge and one of the critical issues to address will be the standardisation of therapy. The more heterogenous the PAT delivery will be across European countries, the more concerned the regulators might be.

On 6th December, we organized our first policy meeting in the European Parliament, looking at the basic ingredients of psychedelic novel treatments captured in the event’s title: “Psychedelic-assisted therapies in the treatment of brain disorders”.

Over 400 people registered for online and in-person attendance, including many EU and government officials. This is a clear sign that Europeans start looking for evidence-based education on psychedelic medicines.

Today, PAREA sent out a communiqué on several significant developments in the area of psychedelic science, policy and regulation that took place in the week of 14 November. You can access this by clicking on this post.

“Despite numerous hurdles, it seems only a matter of time before psychedelics receive (some form of) regulatory green light in Europe.” This is how Sifted.eu - a Financial Times-backed media company covering startups and innovation in Europe – starts its in-dept report “Psychedelics for mental health. Ready for the renaissance”

This Europe-focused report assesses which psychedelic compounds are advancing through the clinical trial process. Analysing which might be best suited to a modern medical model, and considering the various risks of implementation.

This report also studies the regulatory landscape in Europe and asks which markets might open up to psychedelic healthcare soonest. Finally, it looks at the commercial models for psychedelic healthcare companies already functioning in Europe, as well as the emerging digital technologies to try and scale these treatments faster.

PAREA’s Executive Director Tadeusz Hawrot is one of the report’s contributors in Chapter two on European access.

This memorandum singles out the medicinal use of psychedelics (twice) and calls for the EU to become a global regulatory benchmark in this area.

This document suggests that patients ought to have access to novel interventions “including the medical use of psychedelics…especially those who remain resistant to the standard psychiatric care and treatments.”

Click the Resilient Mental Health poster to read the memorandum.

PAREA was invited to speak at Wonderland Miami about the global regulatory approaches to psychedelics. The conference was heavily North American orientated so our European insights were a novel and welcome addition to the conference.

PAREA was quoted in a POLITICO article describing the recent COMPASS clinical trial published in the New England Journal of Medicine. When asked to comment on the prevalence of adverse events in this clinical trial he responded:

”The presumed promise of psychedelic therapies could be a factor and unmet expectations could have fueled feelings of hopelessness and despair amongst non-responders to treatment.”

We welcome the MIND Foundation to PAREA. MIND is a European non-profit science and education organization that promotes psychedelic research and therapy. Their work builds on the neurobiological and psychological potential of psychedelics to improve mental health and well-being in a clinical setting.

Join us for our inaugural event in the European Parliament, co-organised by PAREA and the European Brain Council, where Europe’s leading researchers will discuss the application of psychedelic medicines in various brain disorders and will answer any questions you might have.

We are thrilled to announce that the European Psychiatric Association (EPA) have joined PAREA as a Full Member!

Creating a safe and sustainable integration model will be one of the most critical issues this industry will face as we prepare for the rollout of psychedelic-based medical interventions across Europe.

The oversight and active involvement of the EPA will be indispensable in advancing these major tasks and in building significant medical oversight over psychedelic-assisted therapies in Europe.

Pipeline Innovation Review 2022 released by the EFPIA - European Federation of Pharmaceutical Industries and Associations analyses 8 innovation areas, including psychoplastogens: psychedelics like psilocybin, dissociatives - predominantly ketamine, and empathogens - MDMA. The review anticipates that psychoplastogens are expected to reach the market in short to mid-term and present a potential paradigm shift in our approach to treating some psychiatric disorders. It adds that they are “emerging as feasible, efficacious, and toxicologically safe treatments … and offer a novel approach to MDD care, which may replace the chronic use of anti-depressants and healthcare system resources. … Psychoplastogens may have profound and enduring impact on patients' quality of life, as well as families and caregivers … and nurture enduring equity-oriented care, deepen cultural connections, and decrease socioeconomic costs”. Find out more in the full review or see selection relevant to psychoplastogens.

A deep dive by POLITICO: “Navigating the highs and lows of psychedelic therapies” in which PAREA's Founder underscores the benefits of regulatory oversight for retreats and how they could contribute with real-world evidence. We need to harness a greater understanding of how these medicines affect the body and the mind.

PAREA met with Alexis Goosdeel, Director of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and his four colleagues. EMCDDA plays an important role in terms of providing evidence-based information to policymakers. To that end, PAREA was informed that the agency is currently working on a project to facilitate a greater understanding of the developments in the area of psychedelic substances for medical use.

A related publication is expected around April next year.

PAREA’s founder recently met with members of the European Parliament Alex Agius Saliba and Cyrus Engeler who will facilitate contacts with two EP groups: EU Medicinal Cannabis Alliance and Mental Health CoalitionAdditionally, Mr Hawrot met with Tim Raemekers from DG Research, EC to discuss what opportunities for psychedelic research holds the EU Horizon Europe research programme and Magda Chlebus, from the European Federation of Pharmaceutical Industries and Associations to discuss what are the barriers for big pharma for engaging with psychedelic R&D and to discuss possible project ideas for the Innovative Health Initiative.

At a recent meeting of EMA’s Chief Medical Officer Steffen Thirstrup, PAREA asked the agency to take a lead on bringing various EU institutions, agencies, scientists, and civil society together, similarly to what was done in the US earlier this year by the Federal National Institutes and National Academies. To that end, EMA could co-organize a European workshop with the US FDA and European stakeholders to discuss the future of psychedelic-assisted therapies in Europe.

PAREA met with Director for Health Systems, Medical Products and Innovation - Andrzej Ryś. The Commission is currently performing an extensive revision of the EU General Pharmaceutical Legislation and PAREA was requested to provide additional information on the psychedelic therapies, which could feed into the revision process. Additionally, following PAREA’s suggestion to organize an EU institution-led workshop exploring the future of psychedelics in Europe, the EC advised that PAREA engages with EMA in this regard. EMA would be best placed to organize such an event with the US NIH/FDA and in collaboration with other EU institutions.

The US Drug Enforcement Agency (DEA) recently withdrew a proposal to ban five psychedelic substances thanks to an expert submission from PAREA chair - Professor David Nutt.

Tadeusz Hawrot features in three videos at the 8th Congress of the European Academy of Neurology in Vienna for the Video Journal of Neurology - an independent, global, open-access video journal, dedicated to providing trusted and up-to-date information in order to improve the awareness and understanding of neurology.

Tadeusz Hawrot met with Hugh Laverty, Head of Scientific Operations and Elisabetta Vaudano, Principal Scientific Manager & Responsible Strategic Area Neuroscience. In this meeting they discussed methods to translate health research and innovation into tangible benefits for patients and society, and ensure that Europe remains at the cutting edge of interdisciplinary, sustainable, patient-centric health research.